1. Technical Field
The invention relates to an improved pharmaceutical or dietary composition in form of an aqueous syrup, consisting essentially of (a) vitamins recommended for consumption by children or young adults, (b) a suitable calcium source, (c) at least one dibasic amino acid, (d) taurine, (e) at least one solubilizer, (f) at least one additional agent selected from the group consisting of sweetening agents, flavoring agents, flavor enhancers, preservatives, antioxidants, co-solvents, and (g) water.
2. Background Information
Vitamin and mineral preparations are commonly administered to treat specific medical conditions or as general nutritional supplements. Recent studies have elucidated the important physiological roles played by vitamins and minerals, and established a correlation between deficiencies or excesses of these nutrients and the etiologies of certain disease states in humans. See, e.g., Diplock, “Antioxidant Nutrients and Disease Prevention: An Overview,” Am. J. Clin. Nutr., 53:189-193 (1991); Documenta Geigy Scientific Tables, 457-497, (Diem and Cemtuer eds., 7th ed., 1975).
It has further become recognized that various, groups of the human population require different quantities and types of vitamins and minerals to prevent or alleviate diseases, as well as to maintain general good health. For example, it is known that lysine as an essential amino acid enhances appetite and, together with Vitamin D3, improves the absorption of calcium. The prior art dealing with lysine as nutritional supplement may be best illustrated by the following references:
Albanese A. A. et al., NY State J. Med. 1955; 55, 3453-3456 describe lysine supplementation in infant feeding. Graham G. G. et al., Am. J. Clin. Nutr. 1969; 22 (11), 1459-1468 describe the effect of lysine enrichment of wheat flour for the evaluation in infants. Civitelli R. et al., Nutrition 1992; 8 (6), 400-405, disclose the metabolism of (L)-lysine and calcium in humans. Fürst P., Nutrition 1993; 9 (1), 71-72 suggests (L)-lysine as a nutritional tool in the prophylaxis and treatment of osteoporosis. Flodin N. W., J. Am. Coll. Nutr. 1997; 16 (1), 7-21, reviews the metabolic roles, the pharmacology and the toxicology of lysine.
The International patent application WO 03/035027, for example, discloses a chewable tablet for children comprising a multivitamin composition, lysine and a taste masking agent.
The Russian patent RU 2 189 753 suggests a sterilized milk product for infant nutrition from birthday to five months comprising milk, whey protein concentrate, oils, sugar, minerals, water-soluble vitamins, fat-soluble vitamins, inositol, L-carnitine, taurine and water.
The German utility model DE 201 16 346 U1 discloses a micronutrient combination product based on vitamins, folic acid, magnesium, arginine, coenzyme Q1O, carotenoids and omega fatty acids. However, this document clearly states, that those components have a low miscibility and that it is difficult to obtain homogenous compositions, in particular in aqueous solutions, since some of the components might partly or completely become insoluble or have a low resorbtion in the in the body. Accordingly, DE 201 16 346 U1 suggests to divide the different active ingredients into different dosage forms. Despite the foregoing efforts to improve vitamin, mineral and amino acid supplementation, in particular for children, conventional supplements exhibit several deficiencies. One notable problem is that due to the bad miscibility and the comparably high amount of different vitamins the dosage forms become very voluminous and hard to swallow especially for children.
Problems, thus, arise concerning the compliance of children for taking different dosage forms, in order to have a complete coverage of their needs regarding micronutrients.
Accordingly, there is a need to provide humans, in particular children and/or juveniles with supplementation of essential amino acids and vitamins.
Moreover, the vitamin and mineral preparations available up to now for children do not provide sufficient active ingredients to improve appetite and growth.
It would therefore be desirable to provide a multi-vitamin and mineral supplement for children which overcomes the aforementioned deficiencies of the prior art.